Skip to contents

This tibble contains artificial protocol deviation data for 180 subjects in the Intent-to-Treat (ITT) population of the GT01 study. The dataset contains the usual parameters (PARAM, PARAMCD) for an addv. There is summary parameter (PARCAT1 == "OVERALL") for each subject of the GT01 ITT-population, indicating whether or not at least one major protocol deviation (PD) occurred throughout the course of the study for the respective subject. Individual records for protocol deviations per subject exist, indicating which specific type of PD occurred. The additional flag CRIT1FL, shows whether a PD was related to COVID-19 or not.

Although the data was intentionally created to mimic a typical clinical trial dataset following the CDISC format, it might not strictly comply with CDISC ADaM rules. The intent is to showcase the workflow for clinical table creation rather than creating a fully CDISC-compliant ADaM dataset.

Usage

rx_addv

Format

A tibble with 291 rows and 20 variables:

STUDYID, STUDYIDN

The unique study identifier and its numeric version.

USUBJID

The unique subject identifier.

TRTA, TRTAN

The study intervention and its numeric version, which is either "Placebo" (1), "Drug 1" (2), or NA (3), missing for screen failures).

ITTFL

Intent-to-Treat (ITT) population flag, where "Y" indicates a subject belongs to the ITT population and "N" indicates a subject is not in the ITT population.

AGE

The age of a subject at baseline in years.

AAGEGR1

The analysis age group, indicating if a subject was strictly younger than 40 years at baseline or older.

SEX

Sex of a subject. Can be either "Male", "Female" or "Undifferentiated".

ETHNIC

Ethnicity of a subject. Can be either "Hispanic or Latino", "Not Hispanic or Latino" or missing ("").

BLBMI

Body Mass Index (BMI) of a subject at baseline in kg/m2.

DVTERM

The Protocol Deviation Term.

PARAMCD, PARAM

The Parameter Code and decoded parameter description for the protocol deviation.

PARCAT1

Parameter category. Can be "OVERALL" for derived PD summaries or "PROTOCOL DEVIATION" for individual PDs.

DVCAT

Category for PD, indicating whether the PD is a major one or not.

ACAT1

Analysis category 1. Only populated for individual PDs, not for summary scores. High level category for PDs.

AVAL

Analysis Value. Either 0 or 1.

CRIT1, CRIT1FL

Analysis Criterion 1 and analysis criterion 1 flag, indicating whether PD is related to COVID-19 or not.

Examples

Here is a glimpse at the data available in rx_addv.

dplyr::glimpse(rx_addv)
#> Rows: 291
#> Columns: 20
#> $ STUDYID  <chr> "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01~
#> $ STUDYIDN <chr> "4001", "4001", "4001", "4001", "4001", "4001", "4001", "4001~
#> $ USUBJID  <chr> "GT1001", "GT1002", "GT1002", "GT1003", "GT1003", "GT1003", "~
#> $ TRTA     <fct> Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo~
#> $ TRTAN    <dbl> 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1~
#> $ ITTFL    <chr> "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "~
#> $ AGE      <int> 41, 39, 39, 38, 38, 38, 45, 45, 35, 35, 35, 35, 35, 42, 35, 3~
#> $ AAGEGR1  <fct> >=40, <40, <40, <40, <40, <40, >=40, >=40, <40, <40, <40, <40~
#> $ SEX      <fct> Male, Female, Female, Male, Male, Male, Male, Male, Female, F~
#> $ ETHNIC   <fct> Not Hispanic or Latino, Not Hispanic or Latino, Not Hispanic ~
#> $ BLBMI    <dbl> 33.35073, 30.45862, 30.45862, 22.85986, 22.85986, 22.85986, 2~
#> $ DVTERM   <chr> "", "", "Lab values not taken at month 3", "", "{gt} Question~
#> $ PARAMCD  <fct> PDANYM, PDANYM, PDEV02, PDANYM, PDEV01, PDEV02, PDANYM, PDEV0~
#> $ PARAM    <fct> At least one major Protocol Deviation, At least one major Pro~
#> $ PARCAT1  <chr> "OVERALL", "OVERALL", "PROTOCOL DEVIATION", "OVERALL", "PROTO~
#> $ DVCAT    <chr> "", "", "Major", "", "Major", "Major", "", "Major", "", "", "~
#> $ ACAT1    <chr> "", "", "Study Procedures Criteria Deviations", "", "Study Pr~
#> $ AVAL     <dbl> 0, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1, 1, 1, 0, 1, 1~
#> $ CRIT1    <chr> "COVID-19 Related", "COVID-19 Related", "COVID-19 Related", "~
#> $ CRIT1FL  <chr> "N", "N", "N", "N", "N", "N", "N", "N", "N", "Y", "N", "N", "~

Dataset ID and Badge

DATA-16

This image of that of a dataset badge.

Dataset Introduced

v0.9.0 (Mar 31, 2023)